The Efficacy and Safety of HAIC With FOLFOX vs Sorafenib for Patients Who Showed TACE-resistant: a Retrospective Study

The Efficacy and Safety of Retreatment With Hepatic Arterial Infusion Chemotherapy With Oxaliplatin, Fluorouracil, and Leucovorin vs Sorafenib for Patients Who Showed Transarterial Chemoembolization-resistant: a Retrospective Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05121571

Enrollment

114

Registered

2021-11-16

Start date

2016-04-21

Completion date

2021-05-01

Last updated

2021-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma, TACE failure, Sorafenib, Hepatic arterial infusion chemotherapy, Oxaliplatin, fluorouracil, and leucovorin

Brief summary

Transarterial chemoembolization (TACE) is considered the gold standard for treating intermediate-stage hepatocellular carcinoma (HCC). However, any treatment guidelines do not specify the criteria for repeating TACE. This study was to compare HAIC with FOLFOX with sorafenib who showed TACE-resistant.

Interventions

PROCEDUREHAIC

administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

DRUGSorafenib

sorafenib 400mg bid

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Diagnosed with HCC according to the European Association for the Study of the Liver (EASL) diagnostic criteria * TACE failure/refractoriness by Liver Cancer Study Group of Japan (LCSGJ) criteria * Without extrahepatic metastasis * The following laboratory parameters: Platelet count ≥ 60,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 1.5 mg/dL Serum albumin ≥ 35 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3

Exclusion criteria

* Known history of HIV * History of organ allograft * Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * Serious non-healing wound, ulcer, or bone fracture * Evidence of bleeding diathesis. * Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug

Design outcomes

Primary

Measure	Time frame
Progression free survival	12 months

Secondary

Measure	Time frame	Description
Number of Adverse Events	30 days	—
overall survival	24 months	—
tumor response	6 months	RECIST 1.1

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026